Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Cancer, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2018 |
| Start Date: | August 2013 |
| End Date: | August 2019 |
| Contact: | Rebecca A. Redman, MD |
| Email: | raredm01@louisville.edu |
| Phone: | 502-562-4370 |
Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients
The purpose of this study is to determine if using preventive treatments such as Doxycycline
(an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer
will help to reduce the incidence and severity of the skin rash associated with Cetuximab
(Erbitux®) when compared to receiving standard care for the treatment of skin rash.
(an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer
will help to reduce the incidence and severity of the skin rash associated with Cetuximab
(Erbitux®) when compared to receiving standard care for the treatment of skin rash.
Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment
group and 50 will be in the standard care group. Subjects in the extensive treatment group
will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher,
moisturizer applied to the face, hands, feet, neck, back, and chest each morning after
sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest
each evening.
Subjects will start taking the capsule and applying the creams three days prior to beginning
cetuximab therapy. They will continue this regimen of taking the capsule and applying the
creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the
study doctor may decide to reduce the amount of the dose of cetuximab that they receive or
prescribe other medicines according to standard treatment recommendations, just as he/she
would if the subject was not participating in this study. Subjects will be monitored at
enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for
adherence, side effects and quality of life.
The standard care group will not receive preventive treatment, but they will be allowed to
use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks
into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects
and quality of life.
If a subject is assigned to this group and they develop a severe skin rash, the study doctor
will treat their rash according to standard treatment recommendations, which may include
Hydrocortisone 1% cream, Doxycycline capsules or other medications.
There will be a follow-Up period for both extensive treatment and standard care groups. At 6
months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study
treatment period, they will be contacted by telephone or discussed during their routine
clinic visit.
group and 50 will be in the standard care group. Subjects in the extensive treatment group
will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher,
moisturizer applied to the face, hands, feet, neck, back, and chest each morning after
sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest
each evening.
Subjects will start taking the capsule and applying the creams three days prior to beginning
cetuximab therapy. They will continue this regimen of taking the capsule and applying the
creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the
study doctor may decide to reduce the amount of the dose of cetuximab that they receive or
prescribe other medicines according to standard treatment recommendations, just as he/she
would if the subject was not participating in this study. Subjects will be monitored at
enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for
adherence, side effects and quality of life.
The standard care group will not receive preventive treatment, but they will be allowed to
use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks
into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects
and quality of life.
If a subject is assigned to this group and they develop a severe skin rash, the study doctor
will treat their rash according to standard treatment recommendations, which may include
Hydrocortisone 1% cream, Doxycycline capsules or other medications.
There will be a follow-Up period for both extensive treatment and standard care groups. At 6
months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study
treatment period, they will be contacted by telephone or discussed during their routine
clinic visit.
Inclusion Criteria:
1. Age greater than or equal to 18 years
2. Diagnosis of colorectal or head and neck cancer
3. Receipt of at least one dose of cetuximab during the study time period
Exclusion Criteria:
1. Prior cetuximab treatment within the 6 months of study initiation
2. Current treatment with tyrosine kinase inhibitors
3. Patients who are pregnant or incarcerated
We found this trial at
1
site
529 S Jackson St
Louisville, Kentucky 40202
Louisville, Kentucky 40202
(502) 562-4369
Phone: 502-562-3429
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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